BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P970035 · Supplement: S014 · Decision Nov 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    S670 OVER-THE-WIRE CORONARY STENT SYSTEM
    PMA Number
    P970035
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 16, 1999
    Date Received
    April 21, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Medtronic AVE (AVE) S670 with Discrete Technology(TM) Over-The Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with symptomiatic ischemic heart disease due to discrete de novo lesions (length <30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 and 4.0 mm. Long term outcome (beyond 14 days) for this permanent implant is unknown at present.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MAF Stent, Coronary